Course Description
This course teaches best practices in the design of lyophilization processes for biopharmaceutical products and formulations. The course describes pitfalls to avoid when designing lyophilization processes, and ways to increase efficiency and effectiveness known only to top lyophilization experts.
Instructors
Dr. Muhammad Ashraf (FDA), Dr. Seongkyu Yoon (UMass Lowell), Dr. Akhilesh Bhambhani (Merck), Dr. Robin Bogner (UConn), and William Kessler (Physical Sciences Inc.).
Target Audience
Senior Research Scientist, Bioprocess Engineer, or equivalent in Pharmaceuticals, Biopharmaceuticals
Objective
Describe the fundamental processes involved in lyophilization
Summarize the major considerations involved in formulation design relevant to biologics and their impact on drug product
Describe the process analytical technology used in lyophilization
Describe the critical quality attributes of lyophilized products and their measurement
Summarize the major considerations involved in process design and their impacts on the drug product
Describe some common pitfalls in vial filling in a manufacturing setting
Modules
M1. Introduction to lyophilization
M2. Formulation Development and Characterization
M3. CQAs of Lyophilized Products
M4. Tour of LyoBay
M5. Preparation of test vials; stoppers, sterility concerns, etc.
M6. Initiating lyophilizer cycle
M7. PAT in lyophilization
M8. Lyophilization process design
M9. Evaluation of cakes; residual moisture; pore structure; specific surface area
M10. Collection of vials and collection of relevant data
M11. Data analysis
M12. Process scale-up
Registration
Cost of attendance is $2,500; 50% discount for academic and government. Please head over to BlueSnap to complete your registration.
Contact Information
For any question, please contact bpqc@uml.edu
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